Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074930
Company: FRESENIUS KABI USA

Products on ANDA 074930

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074930

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/13/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74930ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74930ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2024	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/20/2005	SUPPL-4	Labeling		Label is not available on this site.
05/24/2002	SUPPL-2	Labeling		Label is not available on this site.
05/10/2000	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074930

ACYCLOVIR SODIUM

INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203701	EUGIA PHARMA
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	074930	FRESENIUS KABI USA
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	218111	HAINAN POLY
ACYCLOVIR SODIUM	ACYCLOVIR SODIUM	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206535	ZYDUS PHARMS